November 4, 2013

The generic drug gabapentin, which is already widely prescribed for epilepsy and some kinds of pain, appears to be safe and effective in the treatment of alcohol dependence. The finding comes from a 150-patient randomized, placebo-controlled, double blind clinical trial conducted by scientists at The Scripps Research Institute (TSRI).

"Gabapentin's effect on drinking outcomes is at least as large or greater than those of existing FDA-approved treatments," said Barbara J. Mason, Pearson Family Professor and co-director of the Pearson Center for Alcoholism and Addiction Research at TSRI, who led the new research. "Plus it's the only medication shown to improve sleep and mood in people who are quitting or reducing their drinking, and it's already widely used in primary care—that's an appealing combination."

The new research was published by the journal JAMA Internal Medicine on November 4, 2013.

Reducing Cravings, Depression, Sleeplessness

As a relatively safe, effective and well-tolerated drug, gabapentin has the potential to fill a large gap in the treatment of alcohol dependence. About eight and a half-million Americans are thought to have the condition, yet each year only a tiny fraction of them are prescribed one of the FDA-approved medications for alcohol dependence, due in part to the limitations of the existing drugs used for treatment.

The lack of treatment is striking in light of alcoholism's enormous adverse impact on society. In addition to its other effects on the lives of individuals and their families, alcoholism promotes cancer, liver disease, strokes and heart attacks, as well as various other disabilities. Worldwide, about one out of 25 deaths is attributable to alcohol misuse.

In the new study, Mason and her colleagues randomly assigned each of 150 recently abstinent people with alcohol dependence to be treated with 900 mg or 1,800 mg of gabapentin or with a look-alike placebo. Over 12 weeks of treatment, the high-dose group ended up refraining from heavy drinking twice as often as the placebo group (45% vs. 23%) and entirely abstained four times as often (17% vs. 4%). The drug also significantly reduced the number of drinks consumed, as well as patient reports of cravings, depression and sleeplessness. None of the treated patients reported serious side effects.

Patients who received the lower, 900-mg dose of gabapentin showed intermediate benefits compared to the high-dose group, likely reflecting what clinicians call a "dose-response effect"—a good indication that the treatment really is working.

"I think that we can now have confidence in the pharmacological effect of this drug," Mason said.

Filling a Gap

Two FDA-approved therapies for alcohol dependence have been around for decades. The first, disulfiram (Antabuse®), interferes with the body's normal enzymatic breakdown of alcohol, making drinking an unpleasant experience. The second, naltrexone (ReVia®, Vivitrol®), blocks the opioid brain-cell receptors that help mediate the sense of reward during drinking.

Both treatments aim to blunt the pleasure-seeking motivation that helps initiate alcohol dependence. But they are relatively ineffective against the anxiety, depression, sleeplessness and other protracted withdrawal symptoms that help maintain alcoholism once it has been established. They are also, by design, somewhat unpleasant—which often discourages patients from using them.

A newer drug, acamprosate (Campral®), the only other medication approved by FDA for alcoholism treatment, does aim to normalize dysregulation in brain stress systems following acute withdrawal, similar to gabapentin. But it has shown only modest benefits on the whole in clinical trials, with no efficacy noted for mood or sleep.

Gabapentin has a favorable safety profile and appears to work by normalizing levels of the neurotransmitter GABA in an emotion-mediating part of the brain called the amygdala, thereby reducing anxiety and other stress-related withdrawal symptoms. A previous, proof-of-concept study of gabapentin by Mason's group also found effects like those reported in this study in patients with cannabis dependence.

Gabapentin's quieting effect on overactive brain areas has led to its approval by the FDA for treating epilepsy and neuropathic pain. It is also now widely prescribed "off-label" for other pain-related conditions, including migraines.

"I'm excited about the possibility that now more people will get treatment," said Mason. "We really need to do more about treating alcohol dependence."

Related Stories

Scientists at The Scripps Research Institute have found clinical evidence that the drug gabapentin, currently on the market to treat neuropathic pain and epilepsy, helps people to quit smoking marijuana (cannabis). Unlike ...

A smoking-cessation medication may be a viable option for the treatment of alcohol dependence, according to a study by scientists at the National Institutes of Health. The study found that varenicline (marketed under the ...

The drug topiramate, typically used to treat epilepsy and more recently weight loss, may also help people addicted to both cocaine and alcohol use less cocaine, particularly heavy users, researchers in the department of Psychiatry ...

Recommended for you

A pair of researchers affiliated with several institutions in Germany, has found that of a number of drugs used by people for recreational purposes (i.e. for non-medicinal reasons and without a prescription) cannabis is the ...

In 2012, Allen Frances, MD, professor emeritus and former chair of the department of psychiatry at Duke University, cautioned that "Internet Addiction" could be the next new fad diagnosis, complete with "an exuberant trumpeting ...

(Medical Xpress)—Researchers at the University of Adelaide say addictive behaviour such as drug and alcohol abuse could be associated with poor development of the so-called "love hormone" system in our bodies during early ...

A study of binge-drinking rodents suggests that knocking back a few drinks every few days may swiftly reduce one's capacity to control alcohol intake. Scientists at The Scripps Research Institute (TSRI) found signs of cognitive ...

If smoking a cigarette no longer delivers pleasure, will smokers quit? It's the idea behind a nicotine vaccine being created by MIT and Harvard researchers, in which an injection of synthetic nanoparticles prompts the immune ...

A fine-tuned combination of two existing pharmaceutical drugs has shown promise as a potential new therapy for people addicted to cocainea therapy that would reduce their craving for the drug and blunt their symptoms ...

0 comments

Please sign in to add a comment.
Registration is free, and takes less than a minute.
Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.